Operation Calm: VR Nature-Based Mindfulness to Reduce Pediatric Surgical Anxiety

Recruiting now · Not applicable

Conditions studied: Preoperative Anxiety Experienced by the Pediatric Patient

In brief

Operation Calm is a pilot randomized controlled trial investigating the feasibility, acceptability, and preliminary effectiveness of a virtual reality (VR) nature-based mindfulness intervention for reducing preoperative anxiety in children and adolescents aged 10-17 years undergoing surgery. Participants are randomly assigned to either a VR mindfulness condition, which combines immersive 360° nature environments with guided mindfulness exercises, or a standard mindfulness control condition. The study also examines changes in trait mindfulness, wellbeing, and nature connectedness, while monitoring participant engagement and tolerability. Findings will help determine whether VR-enhanced mindfulness is a practical and promising approach for supporting youth facing surgical procedures and will inform the design of future larger-scale clinical trials.

Key facts

Study ID

NCT07694934

Run by

McGill University

People needed

40

Starts

2026-03-10

Expected to finish

2026-12-01

Last updated by the study team

2026-07-10

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric patients aged 10-17 years.
• Scheduled for surgery at SHC-Canada
• Ability to use Virtual Reality (VR) equipment, including wearing VR goggles and following mindfulness program instructions.
• No reported experience with a VR-MBI intervention for anxiety reduction.
• Sufficient proficiency in English or French to understand and follow the VR mindfulness program, complete study-related questionnaires/forms.

You may not qualify if…

• Participant being screened report cognitive or physical impairments that limit the ability to participate in mindfulness exercises or use VR technology (self or parent-report).
• Participant being screened reports severe psychiatric conditions or use of medications that significantly alter anxiety levels (as assessed using the Youth Pediatric Symptom Checklist (self or parent-report).

Where it is running

• Shriners Hospital for Children - Canada — Montreal, Canada (enrolling)

Full record on ClinicalTrials.gov

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